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Claims for Patent: 9,289,586

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Claims for Patent: 9,289,586

Title:Spreading implement
Abstract: An implement for applying a volume of liquid to a treatment surface includes a support onto which is mounted a receptacle. The receptacle defines a reservoir space which receives the liquid. The receptacle includes a wall having a working surface that is used to spread the liquid over the treatment surface. The wall is resiliently deformable such that in use the working surface maintains contact with the treatment surface when spreading the liquid. The implement is used in applying a transdermal lotion to the axilla area of a user. A system for transdermal administration of a physiological active agent from a liquid composition and a method of conducting the same are also provided.
Inventor(s): Bayly; Peter (Victoria, AU), Bayly; Mark Simon (Victoria, AU), Ahlstrom; Magnus (Victoria, AU), Watkinson; Adam Charles (Somerset, GB)
Assignee: ACRUX DDS PTY LTD (Victoria, AU)
Application Number:14/317,412
Patent Claims: 1. A method of transdermal administration of a physiologically active agent from a liquid composition to a subject including: providing an implement having a support, and a receptacle mounted on the support, the receptacle defining a reservoir space with an open top being configured to receive a volume of the liquid composition through the open top, the receptacle including a flexible membrane forming a base and a wall, the wall being substantially perpendicular to the base and having a working surface to spread the liquid composition over a treatment surface of the subject, wherein the base has a continuous surface such that the liquid composition cannot pass through the base, wherein at least the wall is resiliently deformable when spreading the liquid composition over the treatment surface; applying the liquid composition to the reservoir through the open top; and deforming the wall of the receptacle containing the liquid composition against the treatment surface; and spreading the liquid composition over the treatment surface with the working surface of the wall.

2. A method according to claim 1, including providing a container configured to contain the liquid composition, and providing a dispensing device configured to deliver the liquid composition from the container, and dispensing the liquid composition from the container to the receptacle through the open top.

3. A method according to claim 2, wherein the support is configured to detachably connect to the dispensing device, and detaching the support from the dispensing device so as to dispense the liquid composition from the container to the receptacle.

4. A method according to claim 3, wherein the dispensing device includes a pump and the support surrounds the pump when the support is attached to the dispensing device, so as to reduce the likelihood of inadvertent discharge of the liquid composition from the pump.

5. A method according to claim 1, wherein the implement is configured to be used with the treatment surface of the subject which is the subject's skin, and spreading the liquid composition over the subject's skin using the implement.

6. A method according to claim 1, wherein the implement is configured to be used with the treatment surface of the subject which is an axilla area of the subject's skin, and spreading the liquid composition over the axilla area of the subject's skin using the implement.

7. A method according to claim 1, wherein the support is relatively rigid in comparison to the wall of the receptacle, and moving the wall relative to the support when spreading the liquid composition over the treatment surface.

8. A method according to claim 7, wherein the wall collapses relative to the support when spreading the liquid composition over the treatment surface.

9. A method according to claim 1, wherein the liquid composition includes a penetration enhancer.

10. A method according to claim 9, wherein the penetration enhancer is selected from the group consisting of fatty acids, fatty acid esters, fatty alcohols, glycols and glycol esters, 1,3-dioxolanes and 1,3-dioxanes, macrocyclic ketones containing at least 12 carbon atoms, oxazolidinones and oxazolidinone derivatives, alkyl-2-(N,N-disubstituted amino)-alkanoate esters, (N,N-disubstituted amino)-alkanol alkanoates, sunscreen esters and mixtures thereof.

11. A method according to claim 9, wherein the penetration enhancer is one or a mixture of octyl dimethyl-para-aminobenzoate, octyl para-methyoxycinnamate and octyl salicylate.

12. A method according to claim 9, wherein the liquid composition includes from 1 to 15% by weight of the total composition of a penetration enhancer.

13. A method according to claim 1, wherein the liquid composition includes from about 40-90% by weight of volatile solvent selected from the group consisting of ethanol, ethyl acetate, isopropanol, acetone, ethyl formate, methyl acetate, methyl ethyl ketone, pentane, chloroform, dimethyl ether, R134a and mixtures thereof.

14. A method according to claim 1, wherein the physiologically active agent includes at least one hormone selected from the group consisting of oestrogens, progestagens and androgens.

15. A method according to claim 1, wherein the physicologically active agent is an androgen selected from testosterone and derivatives thereof.

16. A method according to claim 1, wherein the liquid composition comprises: (a) a pharmaceutically effective amount of testosterone; (b) one or more of lower alkyl alcohols; wherein the combined amount of lower alkyl alcohols is at least 60% v/v of the composition; (c) one or more penetration enhancers; and (d) a viscosity modulating agent for increasing the viscosity of the composition.

17. A method according to claim 16, wherein the testosterone is present in the liquid composition in an amount of at least 1% w/v.

18. A method according to claim 1, wherein the liquid composition is in the form of a lotion or gel.

19. A method according to claim 1, wherein the liquid composition has a viscosity greater than water and less than 300 centipoise.

20. A method according to claim 1, wherein the subject is a male suffering hypogonadism and the liquid composition is applied to provide a serum testosterone level in the range of from 300 to 1000 ng/dl.
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